BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1569600 · Received December 2, 2009

    Report

    Report Number
    1823260-2009-08148
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 6, 2009
    Report Date
    December 2, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RAN A PT CORRELATION FOR CKMB REAGENT LOT CHANGE AND DETERMINED THERE WAS BOTH A QC AND PT SHIFT SEEN WITH THE NEW REAGENT LOT. CKMB OLD LOT IS 153686, NEW LOT IS 155150. ERRONEOUS PT RESULTS WERE FROM CORRELATION STUDY ONLY, NONE WERE REPORTED OUT OR USED FOR PT DIAGNOSIS. THE PT CORRELATION INVOLVED 20 PT SAMPLES, 11 WERE FOUND TO BE DISCREPANT: SAMPLE 1, USING OLD REAGENT LOT GAVE 3, NEW LOT GAVE 2.38 NG PER ML. SAMPLE 2, USING OLD REAGENT LOT GAVE 2.6, NEW LOT GAVE 1.96 NG PER ML. SAMPLE 3, USING OLD REAGENT LOT GAVE 3.3, NEW LOT GAVE 2.59 NG PER ML. SAMPLE 4, USING OLD REAGENT LOT GAVE 5.5, NEW LOT GAVE 4.47 NG PER ML. SAMPLE 5, USING OLD REAGENT LOT GAVE 2.3, NEW LOT GAVE 1.69 NG PER ML. SAMPLE 6, USING OLD REAGENT LOT GAVE 3.8, NEW LOT GAVE 3.03 NG PER ML. SAMPLE 7, USING OLD REAGENT LOT GAVE 2.7, NEW LOT GAVE 2.05 NG PER ML. SAMPLE 8, USING OLD REAGENT LOT GAVE 2.4, NEW LOT GAVE 1.79 NG PER ML. SAMPLE 9, USING OLD REAGENT LOT GAVE 2.4, NEW LOT GAVE 1.87 NG PER ML. SAMPLE 10, USING OLD REAGENT LOT GAVE 14.9, NEW LOT GAVE 12.41 NG PER ML. SAMPLE 11, USING OLD REAGENT LOT GAVE 4, NEW LOT GAVE 2.68 NG PER ML. A REAGENT BULLETIN, WHICH INCLUDES THE NEW LOT USED BY THE CUSTOMER, HAS BEEN ISSUED COMMUNICATING THE CKBM REAGENT HAS BEEN RESTANDARDIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK